Question NW3407 to the Minister of Health

Reply:

1. (a) It is the Departments of Health’s policy to ensure equitable access to quality healthcare through availability of safe, effective and cost-effective medicines at the appropriate level of care. The National Department of Health (NDoH) manages contracts for approximately 1 200 line items. During the contracting for medicines, it is a special contractual condition that suppliers provide the NDoH with information related to their buffer stock holding, plans within the pipeline and data related to deliveries made to facilities. The NDoH uses this information to manage supplier performance including the imposition of penalties where appropriate. Furthermore, the data is used for planning purposes including demand and supply planning.

Medicine availability is monitored using supplier and provincial level data and this allows visibility of stock availability and as such allows for risk mitigation by the National Department of Health.

However, the recent media reports are of shortages related to availability in the private sector. Availability of the medicines referred to in these reports was above 90% in the public sector. There were no public sector supply challenges of chronic medicines for first and second line agents as reported recently in the media.

(b) There are a number of interventions implemented to reduce supply shortages at facilities. These interventions are informed by the cause of the supply challenge.

• Where the supply constraint may result in a longer term supply challenge, such as regulatory matters including amendments to the dossier that requires approval from South African Health Products Regulatory Authority (SAHPRA), including a change/addition of an active pharmaceutical ingredient source and/or manufacturing site, the transfer of ownership of dossiers which results in a change of marketing authorization, delays in the issuing of the permits for imported medicines, manufactured products requiring additional quality checks by SAHPRA, etc. and no alternative local suppliers with registered products are available; an application would be made to SAHPRA for the acquisition of unregistered medicines for human use in South Africa Act use in terms of Section 21 of the Medicines and Related Substances Act.

• Should the supply constraint be due to operational matters, e.g. machine breakdown, labour unrest, theft, post importation testing, etc., the National Department of Health (NDOH) would source products from alternative local suppliers with registered products using the quotation process.

(c) In any supply chain, shortages can never be eradicated. However, actions can be taken to identify problems that could lead to a supply challenge and to deal with each challenge as it arises. See response in (b) above. Each case is treated individually depending on the root cause, and the magnitude of the supply challenge.

2. In the event that a supply challenge cannot be resolved, a circular is sent to all provinces indicating therapeutic alternatives as per the Standard Treatment Guidelines (STGs) which will guide clinicians to manage patients until supply is sourced.

END.